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Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

RecruitingPhase 3

Sponsor: NYU Langone Health

Conditions: Pulmonary Embolism

Interventions: Anticoagulant Therapy, Catheter-Directed Therapy

Countries: United States

PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and
2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio \> 1 on CT angiography

Exclusion Criteria:

1. Age \< 18 years
2. Systolic blood pressure \< 90 mmHg for \>15 consecutive minutes or \> 40 mmHg drop from baseline, or vasopressor requirement for blood pressure support (i.e., massive PE), occurring within 1 hour prior to eligibility assessment.
3. Symptom duration \> 14 days for the current PE episode
4. Irreversible INR \> 3
5. Irreversible Thrombocytopenia (Platelets \< 50,000/microliter)
6. Creatinine \> 2.0 mg/dl
7. Hemoglobin \< 7.0 g/dl
8. Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential))
9. Allergy or hypersensitivity to Recombinant Tissue Plasminogen Activator (rt-PA), or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used
10. Life expectancy \< 1 year
11. Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)
12. Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
13. Unable or unwilling to provide informed consent
14. Major contraindication or unsuitability for all CDT methods available at the Clinical Center

Locations (40)

Birmingham, Alabama, United States
Palo Alto, California, United States
Sacramento, California, United States
San Diego, California, United States
Torrance, California, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Downers Grove, Illinois, United States
Maywood, Illinois, United States
Springfield, Illinois, United States
Iowa City, Iowa, United States
Portland, Maine, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Ypsilanti, Michigan, United States
St Louis, Missouri, United States
Newark, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
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